In June 2016 the FDA released three new guidance documents, including
a “Questions and Answers” clarifying the responsibilities of both drug
manufacturers and the FDA for navigating “compassionate use” requests
for drugs that have not yet been approved by the FDA. Notable
developments in the final guidance include the FDA’s emphasis on “single
patient expanded access”, provisions and the Agency’s recommendation
that manufacturers publish their expanded access programs and provide
the public with specific points of contact for expanded access requests.
Yet, while the Agency attempts to address manufacturer concerns
regarding how negative outcomes could affect the drug approval process,
manufacturers may not yet be fully ready to embrace expanded access
requests, nor may they be ready to do so. Will the FDA’s announcement
result in drug companies receiving increased compassionate use inquiries
from physicians, and if so how can they prepare to have the processes
in place to handle the requests appropriately? This one hour seminar
will also address:

Form FDA 3926- what manufacturers need to know

Understanding the three categories for expanded access

Category specific requirements

Types of submissions permitted

Designating a point of contact and primary responsibilities

Impact of adverse events on submissions & approvals

Speakers:David FarberPartnerKing & Spalding

Preeya PintoPartnerKing & Spalding

Lisa DwyerPartnerKing & Spalding

Participants
that will find this webinar most beneficial will be those involved in
pharmaceutical companies. Job titles of attendees that will be most
applicable for this session will be: